Validation of Population Pharmacokinetic Model Derived Fr... | NCT02808065

Studies
Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

NCT02808065

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Jun 21, 2016Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Kidney Transplantation

Interventions

Tacrolimus
Mycophenolate mofetil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Oct 2016Estimated

Completion Date

Oct 2016Estimated

First Submitted Date

Jun 17, 2016

First Submission Date that Met QC Criteria

Jun 17, 2016

First Posted Date

Jun 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2016

Last Update Posted Date

Jun 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yon Su Kim, Principal Investigator, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Name	Class
Ministry of Food and Drug Safety, Korea	OTHER_GOV

Description Module

Brief Summary

Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.

Detailed Description

Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tacrolimus + Mycophenolate mofetil			Drug: Tacrolimus Drug: Mycophenolate mofetil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus	Drug	Administered dose were individualized according to their own prescription	Tacrolimus + Mycophenolate mofetil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tacrolimus concentration		0, 1, 2, 3, 4 hours post-dose

Secondary Outcomes

Measure	Description	Time Frame
Mycophenolate concentration		0, 1, 2, 3, 4 hours post-dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of 18 years or older
At least 6 months after kidney transplantation
Were on tacrolimus alone or tacrolimus plus mycophenolate based immunosuppressive regimen
Maintained stable dose of immunosuppressants for at least two weeks

Exclusion Criteria:

AST or ALT >3 upper limit of normal range
Had gastrointestinal disorder that may affect an absorption of drug
Coadministration of drugs that may affect the pharmacokinetics of immunosuppressive drug
Multi-organ transplant recipient
Severe psychiatric disorder
Drug or alcohol abuser
Pregnant
Low compliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

40 kidney transplant recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jae Hyun Kim	Contact	82-2-2072-0335		jaerung90@gmail.com

Overall Officials

Name	Affiliation	Role
Yon Su Kim, M.D., Ph.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-744	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D016559	Tacrolimus
D009173	Mycophenolic Acid

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D002208	Caproates
D000144

Browse Leaves

Not provided

Browse Branches

Not provided